QUÉBEC CITY, Dec. 28, 2012 /PRNewswire/ - Aeterna Zentaris Inc. (NASDAQ:
AEZS) (TSX: AEZ) (the "Company") today announced that it has reached an
agreement with the U.S. Food and Drug Administration ("FDA") on a
Special Protocol Assessment ("SPA") for an upcoming Phase 3
registration trial in endometrial cancer with its doxorubicin peptide
conjugate, AEZS-108. The SPA agreement states that the proposed trial
protocol design, clinical endpoints and planned analyses are acceptable
to the FDA to support a regulatory submission.

"We are pleased with the agreement with the FDA which provides us with a
clearly defined development and regulatory pathway for AEZS-108 in
endometrial cancer", stated Juergen Engel, PhD, President and CEO at
Aeterna Zentaris. "AEZS-108's innovative targeted approach could offer
a new treatment option for women with endometrial cancer and provide
the Company with a significant market opportunity."

Study Design

This will be an open-label, randomized, multicenter Phase 3 trial
conducted in North America and Europe, comparing AEZS-108 with
doxorubicin as second line therapy for locally-advanced, recurrent or
metastatic endometrial cancer. The trial will involve approximately 500
patients and the primary efficacy endpoint is improvement in median
Overall Survival.

About Special Protocol Assessments ("SPA")

The SPA process is a procedure by which the FDA provides official
evaluation and written guidance on the design and size of proposed
protocols that are intended to form the basis for a Biologics License
Application ("BLA") or New Drug Application ("NDA"). Final marketing
approval depends on the results of efficacy, the adverse event profile
and an evaluation of the benefit/risk of treatment demonstrated in the
Phase 3 trial.

About AEZS-108

AEZS-108 represents a new targeting concept in oncology using a hybrid
molecule composed of a synthetic peptide carrier and a well-known
chemotherapy agent, doxorubicin. AEZS-108 is the first intravenous drug
in advanced clinical development that directs the chemotherapy agent
specifically to Luteinizing Hormone Releasing Hormone ("LHRH")-receptor
expressing tumors, resulting in more targeted treatment with less
damage to healthy tissue. The product has successfully completed Phase
2 studies for the treatment of ovarian and endometrial cancer and the
Company is currently planning a Phase 3 trial in endometrial cancer
under a Special Protocol Assessment. AEZS-108 is also in Phase 2 trials
in prostate, breast and bladder cancer. AEZS-108 has been granted
orphan drug designation by the FDA and orphan medicinal product
designation from the European Medicines Agency for the treatment of
ovarian cancer. Aeterna Zentaris owns the worldwide rights to AEZS-108.

About Endometrial Cancer

Endometrial cancer is the most common gynecologic malignancy and
develops when abnormal cells amass to form a tumor in the lining of the
uterus. It largely affects women over the age of 50 with a higher
prevalence in Caucasians and a higher mortality rate among African
Americans. Approximately one in 30 women is diagnosed with endometrial
cancer every year. According to the American Cancer Society, 47,130 new
cases of endometrial are expected to be diagnosed in the United States
in 2012, and Data Monitor expects 35,600 new cases in EU-G5 in 2013,
with about 20% recurrent disease.

About Aeterna Zentaris

Aeterna Zentaris is an oncology and endocrinology drug development
company currently investigating treatments for various unmet medical
needs. The Company's pipeline encompasses compounds at all stages of
development, from drug discovery through to marketed products. For more
information please visit www.aezsinc.com

Forward-Looking Statements

This press release contains forward-looking statements made pursuant to
the safe harbour provisions of the U.S. Securities Litigation Reform
Act of 1995. Forward-looking statements involve known and unknown risks
and uncertainties that could cause the Company's actual results to
differ materially from those in the forward-looking statements. Such
risks and uncertainties include, among others, the availability of
funds and resources to pursue R&D projects, the successful and timely
completion of clinical studies, the risk that safety and efficacy data
from any of our Phase 3 trials may not coincide with the data analyses
from previously reported Phase 1 and/or Phase 2 clinical trials, the
ability of the Company to take advantage of business opportunities in
the pharmaceutical industry, uncertainties related to the regulatory
process and general changes in economic conditions. Investors should
consult the Company's quarterly and annual filings with the Canadian
and U.S. securities commissions for additional information on risks and
uncertainties relating to forward-looking statements. Investors are
cautioned not to rely on these forward-looking statements. The Company
does not undertake to update these forward-looking statements. We
disclaim any obligation to update any such factors or to publicly
announce the result of any revisions to any of the forward-looking
statements contained herein to reflect future results, events or
developments, unless required to do so by a governmental authority or
by applicable law.